RecruitingPhase 1NCT05155189

A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma

A Clinical Study to Evaluate Safety and Efficacy of C-CAR031 Armored CAR-T Cell Injection in Treatment of Advanced Hepatocellular Carcinoma


Sponsor

Zhejiang University

Enrollment

72 participants

Start Date

Feb 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A study that aimed to assess the safety and anti-tumor activity of CCAR031 injection in unresectable HCC patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an engineered immune cell therapy called C-CAR031 — a type of CAR-T cell treatment — for patients with advanced liver cancer (hepatocellular carcinoma, HCC) that has not responded to previous treatments. The engineered cells are designed to recognize and attack a protein called GPC3 found on liver cancer cells. **You may be eligible if...** - You are between 18 and 75 years old with confirmed liver cancer (Barcelona Stage B or C) - Your cancer has progressed on or after at least one prior standard systemic therapy - You have at least one measurable tumor, and your liver function is adequate (Child-Pugh score 6 or less) - Your blood counts and organ function meet the required minimums - Your tumor is likely to express GPC3 **You may NOT be eligible if...** - You have had a prior liver transplant or any prior cell therapy - The tumor takes up more than 50% of your liver - You have cancer that has spread to the brain or bones - You have moderate to severe fluid buildup in the abdomen (ascites) - You are pregnant or breastfeeding - You have active hepatitis C, syphilis, or significant immune system disease - You have severe heart disease or bleeding risks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALC-CAR031

Targeting GPC3 armored CART cell injection (C-CAR031)

DRUGLenvatinib

Tyrosine kinase inhibitors

DRUGRegorafenib (BAY 73-4506)

Tyrosine kinase inhibitors

DRUGDurvalumab

Immune checkpoint inhibitors, ICIs


Locations(2)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

The first affiliated hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT05155189


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